The HeartSine Samaritan Public Access Defibrillator (PAD) 300/300P is the subject of a class 1 recall. Certain Samaritan 300/300P PAD devices, intended for use on patients experiencing sudden cardiac arrest, have been found to intermittently turn on and off, which may eventually deplete the battery. In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event.
Samaritan 300/300P PAD devices with the following serial numbers are affected by this recall:
0400000501 to 0700032917
08A00035000 to 10A0070753
10C00200000 to 10C00210106
Affected devices were manufactured and distributed from 08/01/2004 to 01/31/2011.
This is a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert